Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K201814Substantially Equivalent

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit

Becton Dickinson & Co, San Jose CA / Traditional, Substantially Equivalent

K201814 is the FDA 510(k) clearance record for BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit, a class II device, cleared for Becton, Dickinson and Company on under FDA product code OYE (Flow Cytometric Reagents And Accessories.). FDA's definition for product code OYE reads: "To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level...". FDA records list 345 510(k) clearances for Becton, Dickinson and Company, from to . As of , FDA records show 5 recalls naming K201814.

Clearance record

Decision date
Received
(89 days to decision)
Product code
OYE Flow Cytometric Reagents And Accessories.
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Becton, Dickinson and Company 2350 Qume Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYE

Trailing 12 months

FDA records hold no clearances under product code OYE in the trailing twelve months.

FDA records show no clearances under product code OYE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260